Cerus Corporation Announces Record Fourth Quarter and Full Year 2020 Financial Results

On February 25, 2021 Cerus Corporation (Nasdaq: CERS) reported financial results for the fourth quarter and year ended December 31, 2020 (Press release, Cerus, FEB 25, 2021, View Source [SID1234575634]).

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Recent developments and highlights include:

Record total fourth quarter and full year 2020 revenues of $33.6 million and $114.2 million, respectively. Total revenue was composed of (in millions, except %):

Provided 2021 annual product revenue guidance of $106 million to $110 million, representing an approximately 15% to 20% increase over 2020 reported product revenue.
Received FDA approval for the INTERCEPT Blood System for Cryoprecipitation, which can now be used to produce two products: Pathogen Reduced Cryoprecipitated Fibrinogen Complex (PR-Cryo FC) for the treatment and control of bleeding, including massive hemorrhage, associated with fibrinogen deficiency, and a derivative product, called Pathogen Reduced Plasma, Cryoprecipitate Reduced.
Announced the formation of a joint venture with Shandong Zhongbaokang Medical Implements that intends to develop, register, manufacture and commercialize the INTERCEPT Blood System for platelets and red blood cells in China.
Announced Brazilian distribution partner, CEI, was awarded a three-year tender award for the INTERCEPT Blood System for platelets with the HemoMinas Foundation of Brazil.
Ended 2020 with cash, cash equivalents, and short-term investments of $133.6 million at December 31, 2020.
"The COVID-19 pandemic has fundamentally altered the way the world thinks about pandemic preparedness. As we recognize a record quarter and year for our business, there remains much work to do with blood centers and hospitals around the world to ensure the safety and availability of the blood supply and protect patients from infectious viral diseases and bacterial contaminants. During a year unlike any other, I am proud of the significant commercial momentum we generated in 2020 to help advance pathogen reduced blood products towards the standard of care in transfusion medicine," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "With customers continuing to increase production of INTERCEPT platelets, we are poised for another year of solid top-line growth in 2021. Additionally, our team is working to launch our recently FDA approved Pathogen Reduced Cryoprecipitated Fibrinogen Complex product and to advance our pipeline programs. While we have made tremendous progress, we still have much work to do to realize our mission to safeguard the global blood supply. We look forward to updating our stakeholders as we make progress towards our key milestones over the course of the year."

Revenue

Product revenue during the fourth quarter of 2020 was $28.2 million, compared to $20.9 million during the same period in 2019. Product revenue growth in the quarter benefited from strong continued demand for INTERCEPT platelet kits in the U.S., continued growth in platelet kit demand in EMEA, and strong illuminator sales. For the full year, product revenue totaled $91.9 million, an increase of 23% compared to the same period in 2019.

Although the Company generally had more activity during 2020 for its INTERCEPT red blood cell system covered through its contract with the Biomedical Advanced Research and Development Authority (BARDA), there were a number of COVID-19 related delays and disruptions to clinical activities. Accordingly, government contract revenue primarily from the BARDA agreement was $5.4 million during the fourth quarter of 2020, compared to $5.6 million during the same period in 2019. Full year 2020 government contract revenue totaled $22.3 million compared to $19.1 million in the same period of the year prior. The total potential value of the current BARDA agreement is $214 million, with $66.4 million cumulatively recognized as government contract revenue through December 31, 2020.

BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. The development of the INTERCEPT red blood cell program has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600009C.

Gross Margins

Gross margins on product revenue during the fourth quarter of 2020 were 56.8% compared to 55.6% for the fourth quarter of 2019. The increase in gross margin was tied to increased volumes of INTERCEPT kits sold, driving economies of scale within our production cycle, and favorable foreign exchange rates with a weakening U.S. dollar relative to the Euro. Gross margins on product revenue for the full year 2020 and 2019 were 55.2%.

Operating Expenses

Total operating expenses for the fourth quarter of 2020 were $35.8 million compared to $33.6 million for the same period of the prior year. Full year 2020 operating expenses totaled $131.4 million compared to $126.6 million for the full-year 2019.

Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2020 totaled $18.7 million, compared to $17.2 million for the fourth quarter of 2019. The year-over-year increase in SG&A expenses was tied to increased non-cash stock-based compensation, and investments ahead of the Company’s anticipated PR-Cryo FC launch. Full-year 2020 SG&A expenses totaled $67.0 million compared to $66.2 million for the full-year 2019.

Research and development (R&D) expenses for the fourth quarter of 2020 were $17.1 million, compared to $16.4 million for the fourth quarter of 2019. The year-over-year increase in R&D expenses was largely due to non-cash stock-based compensation and product enhancements and initiatives for expanded label claims. Full-year 2020 R&D expenses totaled $64.4 million compared to $60.4 million for the full-year 2019.

Net Loss

Net loss for the fourth quarter of 2020 was $14.4 million, or $0.09 per basic and diluted share, compared to a net loss of $16.9 million, or $0.12 per basic and diluted share, for the fourth quarter of 2019. Full-year 2020 net loss was $59.9 million, or $0.37 per basic and diluted share, compared to $71.2 million, or $0.51 per basic and diluted share, for the same period in 2019.

Balance Sheet

At December 31, 2020, the Company had cash, cash equivalents and short-term investments of $133.6 million, compared to $85.7 million at December 31, 2019.

At December 31, 2020, the Company had approximately $39.6 million in outstanding term loan debt and $8.5 million of borrowings under its revolving loan credit agreement, compared to $39.4 million in outstanding term loan debt and $5.0 million of borrowings under its revolving loan credit agreement at December 31, 2019.

2021 Product Revenue Guidance

The Company expects 2021 product revenue to be in the range of $106 million to $110 million. The guidance range represents approximately 15% to 20% growth compared to 2020 reported product revenue.

QUARTERLY CONFERENCE CALL

The Company will host a conference call at 4:30 P.M. EDT this afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook. To listen to the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 1267389. The replay will be available approximately three hours after the call through March 11, 2021.

Supernus Announces Fourth Quarter and Full Year 2020 Financial Results

On February 25, 2021 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported financial results for the fourth quarter and full year of 2020, and associated Company developments (Press release, Supernus, FEB 25, 2021, View Source [SID1234575633]).

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"We reported record revenues and operating earnings in 2020 based on the growth of Trokendi XR and Oxtellar XR and the addition of the CNS products acquired during the year," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "Looking ahead, we are preparing for the expected launch of SPN-812 in the second quarter of 2021 and are excited to bring a novel non-stimulant treatment option to the millions of children and adolescents across the U.S. with ADHD."

Commercial Update

Fourth quarter 2020 net product sales were $140.7 million, 44% higher than the same period in 2019, driven by the addition of $39.5 million of net product sales from the commercial products acquired in 2020 and $3.3 million in net product sales growth from Trokendi XR and Oxtellar XR. Full year 2020 net product sales were $509.3 million, 33% higher than full year 2019, driven by the addition of $91.0 million of net product sales from the commercial products acquired in 2020 and $34.9 million in net product sales growth from Trokendi XR and Oxtellar XR.

Product Pipeline Update

SPN-812 – Novel non-stimulant for the treatment of ADHD in children and adults

In February 2021, the Company received notice from the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) resubmission for SPN-812 for the treatment of ADHD in pediatric patients is considered a Class I resubmission, thereby assigning a timeline of two months for review by the FDA and establishing a new Prescription Drug User Fee Act (PDUFA) target action date in early April 2021. The Company is preparing for the commercial launch of SPN-812 for the treatment of ADHD in pediatric patients in the second quarter of 2021, if approved by the FDA.
In December 2020, the Company announced positive results from a Phase III trial in adult patients with ADHD. Assuming approval for pediatric patients, the Company plans to submit a supplemental NDA (sNDA) to the FDA for SPN-812 in adults in the second half of 2021.
SPN-830 (Apomorphine infusion pump) – Continuous treatment of motor fluctuations ("on-off" episodes) in PD

The Company is scheduled to meet with the FDA in March 2021 in a Type A meeting to discuss the contents of the Refusal to File (RTF) letter it received in November 2020 regarding its NDA for SPN-830. In the letter, the FDA requested certain documents and reports to be submitted in support of the application. The Company believes additional testing of the device will be necessary to support the SPN-830 NDA resubmission. Supernus plans to resubmit the SPN-830 NDA after completing discussions with the FDA and the required activities for filing.
SPN-820 – Novel first-in-class activator of mTORC1

Development activities are ongoing, including a multiple-ascending dose study in healthy volunteers, with the goal of initiating a Phase II clinical program in treatment-resistant depression by the end of 2021.
Financial Highlights

Fourth quarter and full year 2020 operating earnings were $43.0 million and $173.7 million respectively, as compared to $40.8 million and $148.6 million in the fourth quarter 2019.

Fourth quarter 2020 net earnings and diluted earnings per share were $30.8 million and $0.57, respectively, as compared to $33.1 million, or $0.62 per diluted share, in the same period last year.

2020 full year net earnings and diluted earnings per share were $127.0 million and $2.36 per diluted share, respectively, as compared to $113.1 million and $2.10 per diluted share, for full year 2019.

As of December 31, 2020, the Company had $772.9 million in cash, cash equivalents and marketable securities, compared to $938.8 million as of December 31, 2019. During 2020, the Company made cash payments of approximately $300 million related to the acquisition of the CNS portfolio of US WorldMeds and $25 million to Navitor upon executing the development and option agreement for SPN-820.

Full Year 2021 Financial Guidance

1) Total revenues include net product sales and royalty revenue. Include $10 million for SPN-812 net product sales.
2) Combined research and development and selling, general and administrative expenses.
3) Operating earnings include amortization of intangible assets and contingent consideration expense.

Conference Call Details

The Company will hold a conference call hosted by Jack Khattar, President and Chief Executive Officer and Jim Kelly, Executive Vice President and Chief Financial Officer, to discuss these results at 4:30 p.m. Eastern Time, on Thursday, February 25, 2021.

Please refer to the information below for conference call dial-in information and webcast registration. Callers should dial in approximately 10 minutes prior to the start of the call.

Redx Pharma to present at the Cowen 41st Annual Health Care Conference

On February 25, 2021 Redx Pharma (AIM:REDX), the drug discovery and development Company focused on oncology and fibrosis, reported that Lisa Anson, Chief Executive Officer, will give an update on progress made by the Company, at the Cowen 41st Annual Health Care Conference on Thursday 4 March, 2021 at 16:10 GMT / 11:10 EST (Press release, Redx Pharma, FEB 25, 2021, View Source [SID1234575632]).

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Cellectis to Hold Fourth Quarter 2020 Earnings Call on Friday, March 5, 2021 at 8:00AM EST

On February 25, 2021 Cellectis (Euronext Growth: ALCLS; Nasdaq: CLLS), a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), reported that it will report its financial results for the fourth quarter and full year ending December 31, 2020, on Thursday, March 4, 2021, after the close of the US market (Press release, Cellectis, FEB 25, 2021, View Source [SID1234575631]). The announcement will be followed by a conference call at 8:00 AM EST / 2:00 PM CET on Friday, March 5, 2021, prior to the open of the US market.

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Upstate professor lands $1.1 million NIH grant to study tumor cell growth related to metastatic cancer

On February 25, 2021 An Upstate Medical University assistant professor and researcher reported that it has been awarded a $1.1 million, four-year National Institutes of Health grant to study what makes tumor cells grow and spread throughout the body (Press release, SUNY Upstate, FEB 25, 2021, View Source [SID1234575630]).

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Dimitra Bourboulia, PhD, assistant professor of urology and biochemistry and molecular biology, is principal investigator of the awarded project, "Regulation of the Extracellular Hsp90 Chaperone Machinery." Bourboulia has been investigating for more than a decade the regulation and function of secreted proteolytic enzymes (MMPs), predominantly in tumors that invade through the surrounding tissue. Her latest NIH grant will fund how multiple regulators (activators and inhibitors) interact and signal outside the cell to tweak the activity of MMPs.

Normally, cells release proteins that function to build and maintain a healthy surrounding environment called the extracellular matrix (ECM). The ECM is a well-organized supporting 3D structure. In some diseases including neurodegenerative, cardiovascular and cancer, the ECM can be damaged because protein-degrading enzymes (MMPs) fail to perform their function in a normal way.

"This research essentially focuses on key secreted proteins and their binding partners that function as a team not inside, but outside the cell," Bourboulia said. "If we want to therapeutically target invasive tumors and limit their spread, we need to understand what makes this extracellular Hsp90 pro-invasive machinery so powerful. Unfortunately, we know how only very few components of this machinery.

Bourboulia said she hopes the research will help to better understand how key secreted factors such as Hsp90 chaperone and TIMP2 inhibitor coordinate their binding to one another and to MMP2 to regulate the process of invasion.

"Current therapeutics target one single factor," she said, noting that while medications are designed to work effectively against single proteins, their efficiency drops against those proteins that make complexes, such as the Hsp90:MMP2 complex. "We have proposed that unless we determine at the molecular level how these proteins interact, only then will we design an effective strategy to prevent specifically these undesirable complexes from happening."

The study has direct ties to many human cancers such as kidney, prostate, breast and lung with a focus on cases where aggressive tumors have metastasized or are spreading throughout the body.

Bourboulia, who has worked at Upstate since 2013, said she is lucky to work with a talented team at Upstate including graduate students and residents from the Urology Department – as well as external collaborators – on this project, which could lead to better treatments for aggressive cancers.

"Being integrated with clinical experts here at Upstate Urology is an effective way to translate our bench discoveries and observe their clinical impact," she said. In addition, she feels fortunate to receive the NIH grant despite the many challenges associated with the ongoing COVID-19 pandemic. "There are a limited number of scientists working in this particular field, so we are very fortunate that NIH finds it exciting."

Bourboulia is an expert in extracellular protein signaling and homeostasis. She serves as the assistant dean for UME and GME Research, and Director of the Office of Research for Medical students at Upstate. She participates as panel member at the CDMRP Kidney Cancer scientific peer review team, and as ad hoc reviewer for many high impact scientific journals. Because of her contribution in deciphering the function of extracellular Hsp90 in cancer, Bourboulia was presented with the 2020 Ritossa Early Career Award by the Cell Stress Society International.